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临床试验/NCT01287403
NCT01287403已完成不适用

Response of Alkylresorcinols and Other Biomarkers to Different Cereals

Société des Produits Nestlé (SPN)2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2011年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
14
试验地点
2
主要终点
Plasma Alkylresorcinol Compounds

研究概览

简要总结

Cereal grains contain a wide variety of different phytochemicals which may play different roles in physiology. Their response in plasma and urine after a meal is poorly defined for most cereals. This study will investigate the plasma response and urinary excretion of cereal compounds after eating 6 different types of cereal preparation, with a focus on alkylresorcinols.

详细描述

This was a cross-over, randomized, double blind study with 6 arms (flours of different composition). Thirteen subjects completed the trial, where 100 g of each flour, mixed with 300 mL milk, was fed to all subjects.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Normal-overweight (BMI 19-28 kg/m2)
  • Non-smokers

排除标准

  • Regular consumers of wholegrain cereals
  • Allergy to cereal or milk products

研究组 & 干预措施

Refined wheat flour

Placebo Comparator

A negative control flour to serve as a reference.

干预措施: Esterase wholegrain wheat flour (Other)

Refined wheat flour

Placebo Comparator

A negative control flour to serve as a reference.

干预措施: Wholegrain wheat flour (Other)

Refined wheat flour

Placebo Comparator

A negative control flour to serve as a reference.

干预措施: Liquid whole grain wheat flour (Other)

Refined wheat flour

Placebo Comparator

A negative control flour to serve as a reference.

干预措施: Wholegrain barley flour (Other)

Refined wheat flour

Placebo Comparator

A negative control flour to serve as a reference.

干预措施: Liquid wholegrain barley flour (Other)

Esterase wholegrain wheat flour

Active Comparator

Wholegrain wheat flour treated with esterases to release phenolics (positive control for phenolic acids)

干预措施: Refined wheat flour (Other)

Esterase wholegrain wheat flour

Active Comparator

Wholegrain wheat flour treated with esterases to release phenolics (positive control for phenolic acids)

干预措施: Wholegrain wheat flour (Other)

Esterase wholegrain wheat flour

Active Comparator

Wholegrain wheat flour treated with esterases to release phenolics (positive control for phenolic acids)

干预措施: Liquid whole grain wheat flour (Other)

Liquid whole grain wheat flour

Experimental

Test flour with unknown response.

干预措施: Wholegrain barley flour (Other)

Esterase wholegrain wheat flour

Active Comparator

Wholegrain wheat flour treated with esterases to release phenolics (positive control for phenolic acids)

干预措施: Wholegrain barley flour (Other)

Esterase wholegrain wheat flour

Active Comparator

Wholegrain wheat flour treated with esterases to release phenolics (positive control for phenolic acids)

干预措施: Liquid wholegrain barley flour (Other)

Wholegrain wheat flour

Experimental

Flour with unknown response

干预措施: Refined wheat flour (Other)

Wholegrain wheat flour

Experimental

Flour with unknown response

干预措施: Esterase wholegrain wheat flour (Other)

Wholegrain wheat flour

Experimental

Flour with unknown response

干预措施: Liquid whole grain wheat flour (Other)

Wholegrain wheat flour

Experimental

Flour with unknown response

干预措施: Wholegrain barley flour (Other)

Wholegrain wheat flour

Experimental

Flour with unknown response

干预措施: Liquid wholegrain barley flour (Other)

Liquid whole grain wheat flour

Experimental

Test flour with unknown response.

干预措施: Refined wheat flour (Other)

Liquid whole grain wheat flour

Experimental

Test flour with unknown response.

干预措施: Esterase wholegrain wheat flour (Other)

Liquid whole grain wheat flour

Experimental

Test flour with unknown response.

干预措施: Wholegrain wheat flour (Other)

Liquid whole grain wheat flour

Experimental

Test flour with unknown response.

干预措施: Liquid wholegrain barley flour (Other)

Wholegrain barley flour

Experimental

Test flour with unknown response.

干预措施: Refined wheat flour (Other)

Wholegrain barley flour

Experimental

Test flour with unknown response.

干预措施: Esterase wholegrain wheat flour (Other)

Wholegrain barley flour

Experimental

Test flour with unknown response.

干预措施: Wholegrain wheat flour (Other)

Wholegrain barley flour

Experimental

Test flour with unknown response.

干预措施: Liquid whole grain wheat flour (Other)

Wholegrain barley flour

Experimental

Test flour with unknown response.

干预措施: Liquid wholegrain barley flour (Other)

Liquid wholegrain barley flour

Experimental

Test flour with unknown response.

干预措施: Refined wheat flour (Other)

Liquid wholegrain barley flour

Experimental

Test flour with unknown response.

干预措施: Esterase wholegrain wheat flour (Other)

Liquid wholegrain barley flour

Experimental

Test flour with unknown response.

干预措施: Wholegrain wheat flour (Other)

Liquid wholegrain barley flour

Experimental

Test flour with unknown response.

干预措施: Liquid whole grain wheat flour (Other)

Liquid wholegrain barley flour

Experimental

Test flour with unknown response.

干预措施: Wholegrain barley flour (Other)

结局指标

主要结局

Plasma Alkylresorcinol Compounds

时间窗: From 0 to 48 h post dose.

Area under the curve (AUC) over baseline of alkylresorcinol compounds are measured for the 6 interventional arms. Time points are: t = 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24 and 48 h after product intake.

次要结局

  • Phenolic Acids(0-48 h post dose)
  • Plasma and Urinary Betaine(From 0 to 48 hours post dose)

研究者

发起方
Société des Produits Nestlé (SPN)
申办方类型
Industry
责任方
Principal Investigator
主要研究者

CDUuser

MD, PhD

Société des Produits Nestlé (SPN)

研究点 (2)

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Response of Alkylresorcinols to Different Cereals | 临床试验